Regulatory and Legal
A Patently Good Idea
James Isbester To executives in the medical device community, the routine was well known: The company learns about a competitor’s patent that might apply to the company’s products and asks its lawyers to investigate. If adequate grounds exist, those lawyers...
Preventive Medicine
Device manufacturers face regulatory scrutiny on both federal and state levels for all activity in the life cycle of a product. Proposed regulations in New Jersey and pending legislation in New York suggest that this thicket of federal and state regulations governing both the device...
Highlights of Proposed Changes to 510(k)
Some of the important changes proposed by FDA’s report include the following:   Introduction of Class IIb Devices. These devices, which may include implantable or life-sustaining devices, would usually require the submission of clinical data and manufacturing data in the...
FDA Continues Campaign to Upgrade Quality
For the third time in as many months, CDRH in July sent out letters to a whole industry segment urging the manufacturers to upgrade their products and procedures in the interest of public safety. This time, it was enteral feeding tube manufacturers. In April, it was external...
Deciphering De Novo Reviews
Ladin Imhoff Medical device manufacturers interested in marketing their products in the United States are required to secure FDA marketing clearance. The process for securing such a clearance is generally based on the device’s risk level: Class I (lowest risk)...
User Fee Rates Announced
Table I. Medical device user fees for FY 2011. FDA has announced the user fee rates for FY 2011. Federal law stipulates that the fee rate for each submission type is set at a specified percentage of the standard fee for a premarket approval (PMA) application. For FY 2011,...
A Stricter 510(k) Process Offers Challenges, Promises
FDA has released its long-awaited plans to shore up the 510(k) clearance system used to get many medical devices to market. In August, the agency published a 120-page report to define which devices are appropriate for the approval pathway and when those applications would require...
U.S. Focuses Enforcement on Manufacturers
Judith A. Waltz Recent legal settlements with medical device manufacturers indicate that the federal government has focused enforcement activity on how providers are billing products to government healthcare programs. Coming under the False Claims Act (FCA), these...
Risky Business
Caryn Silverman Evan Smith The Medical Device Safety Act of 2009 (MDSA)—H.R. 1346—was introduced by Representatives Frank Pallone Jr. (D–NJ), chair of the Energy and Commerce Subcommittee on Health, and Henry A. Waxman (D–CA), chair of the Energy...
Just Say No to FDA’s Idea of Transparency
FDA’s proposals to increase transparency have struck a nerve with medical device makers, and industry association Adva­Med has come out with both fists swinging. In a 21-page letter to the agency, AdvaMed blasts the proposals, many of which involve divulging proprietary...